Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT03719105
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054066', 'term': 'Leukemia, Large Granular Lymphocytic'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}], 'ancestors': [{'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C000595188', 'term': 'calaspargase pegol'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000079963', 'term': 'Brentuximab Vedotin'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cohort 1 and 2 will be based on initial diagnosis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '1 year', 'description': 'to assess overall response rate following chemoimmunotherapy induction therapy'}], 'secondaryOutcomes': [{'measure': 'event free survival', 'timeFrame': '2 year', 'description': 'to determine the event free survival after induction chemoimmunotherapy and allogeneic stem cell transplantation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NK-Cell Lymphoma', 'NK-Cell Leukemia', 'Peripheral T Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Patients are in 2 cohorts:\n\nCohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX) (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide, doxorubicin, and prednisone in children, adolescent, and young adults with advanced peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) .\n\nBoth groups proceed to allogeneic stem cell transplant with disease response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '31 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must weigh at least 10 kilograms at the time of the study enrollment.\n* Diagnosis\n\nNewly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:\n\nCOHORT 1\n\n* Aggressive NK cell leukemia (ICD-O code 9948/3)\n* Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2\n* Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)\n* Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)\n* Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)\n* Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)\n* Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for Staging).\n\n * Organ Function Requirements\n\nAdequate liver function defined as:\n\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.\n* ALT (SGPT) \\< 3 x ULN for age.\n\nAdequate cardiac function defined as:\n\n* Shortening fraction of ≥ 27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by radionuclide angiogram.\n\nAdequate pulmonary function defined as:\n\n• Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry \\> 92% while breathing room air unless current dysfunction is due to the lymphoma, in which case the patient is eligible.\n\nExclusion Criteria:\n\n* Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)\n* Patients with active CNS disease.\n* Patients with stage I or stage II disease (See Appendix III for Staging).\n* Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.\n* Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if started on protocol therapy not more than one week from the start of radiotherapy or steroids.\n* Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.\n* Lactating females, unless they have agreed not to breastfeed their infants.\n* Patients with Down syndrome.\n* Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The topical use of these medications (if applicable) is allowed.\n* Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these medications (if applicable) is allowed.\n* Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).'}, 'identificationModule': {'nctId': 'NCT03719105', 'briefTitle': 'Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'New York Medical College'}, 'officialTitle': 'Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study', 'orgStudyIdInfo': {'id': 'NYMC 575'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Patients with aggressive NK cell leukemia or stage III or IV extranodal NK/T-cell lymphoma, nasal type.\n\nChemotherapy Regimen:\n\nmSMILE: Methotrexate Day 1, Ifosfamide Days 2-4, Dexamethasone Days 2-4, Etoposide Days 2-4, calaspargase pegol Day 8. For patients in CR and no available allogeneic SCT can receive up to 2 additional cycles of mSMILE.\n\nPembrolizumab: For patients in PR/MR/NR/PD after 2 cycles of mSMILE.\n\nAllogeneic Stem Cell Transplant if donor available and not in PD.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ifosfamide', 'Drug: Dexamethasone', 'Drug: Etoposide', 'Drug: calaspargase pegol']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Patients with stage III or IV peripheral T-cell lymphoma-NOS, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, or enteropathy-associated T-cell lymphoma (other histologies will be considered after case-by-case discussion with Study Chairs and Executive Vice-Chairs).\n\nChemotherapy Regimen:\n\nCycle 1 \\& 2: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 3 \\& 5: Brentuximab vedotin Day 1, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 4 \\& 6: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Allogeneic Stem Cell Transplant if donor available and not in PD.', 'interventionNames': ['Drug: pralatraxate,', 'Drug: cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Prednisone', 'Drug: Brentuximab Vedotin']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 1']}, {'name': 'pralatraxate,', 'type': 'DRUG', 'description': 'Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Ifosfamide', 'type': 'DRUG', 'description': 'Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 1']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 1']}, {'name': 'calaspargase pegol', 'type': 'DRUG', 'description': 'Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 1']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 2']}, {'name': 'Brentuximab Vedotin', 'type': 'DRUG', 'description': 'Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35223', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana Xavier, MD', 'role': 'CONTACT', 'email': 'axavier@peds.uab.edu'}], 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92968', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carol Lin, MD', 'role': 'CONTACT', 'email': 'clin@choc.org'}], 'facility': "Children's Hospital Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'MIchelle Hermiston, MD', 'role': 'CONTACT', 'email': 'michelle.hermiston@ucsf.edu'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Troy Quigg, MD', 'role': 'CONTACT', 'email': 'troy.quigg@spectrumhealth.org'}], 'facility': 'Helen De Vos', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchell Cairo, MD', 'role': 'CONTACT', 'email': 'mitchell_cairo@nymc.edu', 'phone': '914-594-3650'}, {'name': 'Lauren Harrison, MSN', 'role': 'CONTACT', 'email': 'lauren_harrison@nymc.edu', 'phone': '617-285-7844'}], 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Audino, MD', 'role': 'CONTACT', 'email': 'Anthony.Audino@nationwidechildrens.org'}], 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Ana Xavier', 'role': 'CONTACT', 'email': 'axavier@peds.uab.edu', 'phone': '(205) 638-6763'}, {'name': 'Lauren Harrison', 'role': 'CONTACT', 'email': 'lauren_harrison@nymc.edu', 'phone': '6172857844'}], 'overallOfficials': [{'name': 'Mitchell Cairo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New York Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice-Chair', 'investigatorFullName': 'Mitchell Cairo', 'investigatorAffiliation': 'New York Medical College'}}}}